TWI753579B - High efficiency external counter pulsation system and method of treatment using the system - Google Patents

Abstract

An external counter pulsation system (ECP) and method for using the system to improve circulation as well as cardiovascular related diseases. The ECP system of the present invention comprises a helical air bladder for modulating blood flow of major veins and arteries of the thigh. High efficiency is realized with the helical shape of the air bladder to lower the cost, weight and size of the ECP of the present invention.

Description

High-efficiency external counterpulsation system and treatment method using the same

The present invention relates to a high-efficiency external counterpulsation system and a treatment method using the same. Specifically, the invention includes one or more balloons that utilize the helical shape of the user's femoral aortic vessels and main cardinal venous vessels to achieve high performance.

The external counterpulsation system is a clinically proven system that uses airbags on the patient's legs to regulate hemodynamics, and can effectively treat various diseases including angina pectoris, acute myocardial infarction, stagnant heart failure and ischemic diseases. Other applications are being developed in the fields of neurology and urology. However, current external counterpulsation systems are expensive, bulky, heavy, and difficult to move, one of the reasons being that a high-power air compressor is required to drive the system. Therefore, only hospitals and clinics are sufficient to purchase and fix them, resulting in patients having to go back and forth between different institutions when receiving external counterpulsation systems.

Airbag design can substantially affect the performance of the external counterpulsation system, including body size and power consumption. The present invention discloses a high-efficiency external counterpulsation system based on a new type of helical pressure airbag. The helical pressure airbag utilizes the helical shape of the aortic blood vessels and the main venous blood vessels in the thigh surrounding the femur, so that the aortic blood vessels and the main venous blood vessels are in close contact with each other. thigh bone, and effectively regulate blood flow. Therefore, the arterial vessels are subjected to the force of the helical pressure balloon and the reaction force of the femur to take full advantage of the applied pressure. In the present invention, an auxiliary air bag is installed at one end of the helical pressure air bag to further push the blood flow to the desired direction after the arterial blood vessel is compressed, and a specially designed air bag jacket is used to cover the air bag to ensure that the air bag can be effectively inflated. deliver high air pressure to arterial vessels. The invention discloses a whole group of gas pipeline circuits and a corresponding control method, so that the high-efficiency external counterpulsation system can operate smoothly. The present invention substantially reduces the power consumption of the air compressor through the performance provided by the new spiral pressure airbag, thereby reducing the cost, size and weight of the external counterpulsation system of the present invention, which is convenient for ordinary people to purchase and use at home.

The present invention relates to a high-efficiency external counterpulsation system device, which includes an air bag system, the air bag system includes one or more helical pressure air bags and one or more auxiliary air bags, wherein each helical pressure air bag is adhered to the user's thigh When going up, it will form a spiral along with the aortic blood vessels and main venous blood vessels on the femur. When the spiral pressure balloon is inflated, it will exert effective pressure on the aortic blood vessels and/or main venous blood vessels and stick to the femur to adjust the pressure. blood flow in the aortic and main venous vessels; a valve and fluid system connected to the balloon system, wherein the valve and fluid system are configured to inflate or deflate the helical pressure balloon and accessory balloons; and a control system , which includes a processing unit and one or more photoplethysmography (PPG) sensors and one or more electrocardiogram (ECG) sensors, wherein the PPG and ECG sensors are connected to the user to collect PPG and ECG signals derived from the user, and wherein the control system is electrically connected to the valve and fluid system to control the valve and fluid system, and to inflate the air bags in the air bag system based on the signals measured by the sensors or exhaust.

In a specific embodiment, the size of the helical pressure balloon is determined by the skeletal structure of the user, so that the helical pressure balloon can follow the aortic and main venous vessels of the user's thigh. In another specific embodiment, the length L of the helical pressure bladder is in centimeters, and is defined as "user's height/3.2-b", where b is between 15 cm and 30 cm, the helical pressure The top width and bottom width of the airbag are about 14 cm each, and the helix angle is about 55°. In yet another specific embodiment, the power of the valve and fluid system is less than about 1500 watts.

In a specific embodiment, the length L of the helical pressure airbag is not more than 50 cm, W1 and W2 shall not exceed 25 cm, and the area shall not exceed 1250 square cm. In another specific embodiment, the pressure in the helical pressure bladder does not exceed 350 mmHg when fully inflated. In another specific embodiment, the pressure in the helical pressure bladder is not less than about 150 mmHg when fully inflated. In yet another specific embodiment, the ratio of the top width W1 to the bottom width W2 of the helical pressure bladder is about 1:1 to 2:1.

In a specific embodiment, the helical angle of the helical pressure bladder is between about 30° and 75°. In another specific embodiment, the auxiliary air bag is located at the lower end of the helical pressure air bag and covers the helical pressure air bag. In yet another specific embodiment, the auxiliary air bag is located at the lower end of the helical pressure air bag, but does not cover the helical pressure air bag.

In a specific embodiment, the auxiliary air bag is located at the upper end of the helical pressure air bag and covers the helical pressure air bag. In another specific embodiment, the auxiliary air bag is located at the upper end of the helical pressure air bag, but does not cover the helical pressure air bag. In yet another embodiment, both the auxiliary bladder and the helical pressure bladder are located in the same bladder casing.

The present invention also relates to a method for using the external counterpulsation system of the present invention to provide external counterpulsation therapy, which comprises detecting the R Peak of the user's heartbeat, placing a delay of about 10ms to 250ms after the R Peak, and making the accessory balloon Inflate, insert a delay of about 20ms to 100ms, inflate the helical pressure air bag to provide a treatment effective time of about 200ms to 600ms, make the auxiliary air bag and the helical pressure air bag deflate at about the same time, and repeat steps af to Provide a treatment effective time.

10: External counterpulsation device

100: Airbag Cover System

105: Spiral pressure bladder jacket

110: Spiral pressure bladder

112: Width W1

114: Width W2

116: Length L

118: helix angle

120: Airbag jacket fixing parts

160: Attached airbag jacket

170: Auxiliary airbag

180: width W

185: Length L

200: External Counterpulsation Control System

210: External Counterpulsation Processing Unit

220:PPG sensor

220a: Finger Sensor

220b, 220c: Toe sensor

230: ECG sensor

230a: Right chest sensor

230b: Left chest sensor

230c: Leg Sensor

240: Continuous blood pressure sensor

250: Interactive Display Unit

260: Circuit Connection

300: Valves and Fluid Systems

310: Airbag valve

310a, 310b: Valves

320: Air storage tank after pressure regulation

330: Air pressure proportional adjustment valve

340: Air Compressed Air Storage Tank Air Storage Tank

350: Air Compressor

360, 360a, 360b: Teleporters

370: Air supply valve

375: Air Inlet

380: Atmospheric gas line

390, 395: Small gas lines

1100-1315: Procedure

Figure 1 illustrates the helical geometry of the user's femoral aortic vessels and main venous vessels, and an embodiment of the helical pressure balloon of the present invention 10 .

Figure 2 is a high-level block diagram of the present invention.

Figure 3 is a detailed illustration of one embodiment of the helical pressure bladder casing 105 and the accompanying bladder casing 160 of the present invention.

Figures 4a and 4b illustrate two possible different ways of positioning the helical pressure bladder casing 105 and the auxiliary bladder casing 160 of the present invention.

Figures 4c and 4d illustrate two possible different ways when both the helical pressure bladder 110 and the auxiliary bladder 170 of the present invention are located in the same bladder casing.

Figures 5a and 5b illustrate the inflation and exhaust cycles of the external counterpulsation device of the present invention 10, which are related to the heartbeat cycle and blood flow when the auxiliary air bag 170 is located at the lower end of the helical pressure air bag 110 .

Figures 6a and 6b illustrate the inflation and exhaust cycles of the external counterpulsation device of the present invention 10, which are related to the heartbeat cycle and blood flow when the auxiliary air bag 170 is located at the upper end of the helical pressure air bag 110.

FIG. 7 is a block diagram illustrating an embodiment of the external counterpulsation control system 200 of the present invention.

FIG. 8 is a block diagram illustrating an embodiment of the external counterpulsation control system 200 and valve and fluid system 300 of the present invention.

FIG. 9 is a block diagram illustrating an embodiment of a valve and fluid system 300 of the present invention.

FIG. 10 is a flow chart illustrating an embodiment of a method of using the external counterpulsation device 10 of the present invention.

FIG. 11 is a combined view of PPG and ECG, which shows the process of inflation and deflation of the spiral pressure airbag 110 and the auxiliary airbag 170, wherein the time of the above-mentioned graphs are all adjusted to the same, so as to illustrate the use of the present invention 10 in vitro A specific embodiment of the treatment method of the counterpulsation device.

Figures 12a and 12b show an example of the PPG and ECG signals of the user before and during the treatment using the external counterpulsation device 10 of the present invention.

FIG. 13 shows an exemplary embodiment of the external counterpulsation control system 200 and the valve and fluid system 300 in the external counterpulsation device of the present invention.

In this description and the appended claims, the singular terms "a," "an," and "the" also refer to the plural unless otherwise specified. Therefore, taking "an ingredient" as an example, the description includes a mixture of multiple ingredients, and "an active pharmaceutical preparation" includes more than one active pharmaceutical preparation.

As used herein, the term "about" is used to modify a quantity that refers to plus or minus 5% of the quantity and the quantity itself.

The term "effective time" or "therapeutic effective time" for a treatment refers to a period of time that is sufficient and non-toxic/harmless to provide the desired therapeutic effect. The length of time "effective" varies from subject to subject, depending on the age or general condition of the individual, or individual circumstances.

Compared with the conventional external counterpulsation device, the external counterpulsation device 10 of the present invention can achieve miniaturization, low energy consumption, and low cost. This is because the external counterpulsation device of the present invention utilizes aortic blood vessels and main veins. The geometry of the blood vessels encircling the femur in a spiral shape, as shown in Figure 1. Specifically, as shown in Figure 1, the aortic blood vessels and the main venous blood vessels start from the front of the femur in front of the pubic bone, circle the inner thigh in a spiral shape, then go around the back of the femur behind the knee, and finally toward the leg Extend below. As shown in FIG. 1, the helical pressure balloon 110 has a shape that can utilize this specific bone structure, so that the helical pressure balloon 110 can concentrate the energy transfer to the aortic blood vessels and the main venous blood vessels close to the thigh area of the femur, so as to Regulates blood flow in the aorta and main venous vessels without wasting energy in other areas of the thigh. The condition to achieve this effect is the need for a smaller and lower power air compressor, so that the effect is the same as or better than the traditional external counterpulsation system. For example, the power consumption of the present invention is lower than 500, 600, 700, 800, 900, 1000, 1250 or 1500 watts, while the power consumption of a commercially available external counterpulsation system is about 2500 watts. In addition, the characteristics of miniaturization make the external counterpulsation device of the present invention 10 easy to operate and even carry, its weight is less than about 20, 25, 30 kg, and the cost is substantially lower than the existing external counterpulsation device, which is generally heavier. , therefore designed to be non-removable. In other words, the user can purchase and operate the external counterpulsation device of the present invention 10 at home without having to go to the clinic for treatment.

FIG. 2 is a high-level diagram of the external counterpulsation device 10 of the present invention 10 , which includes an airbag system 100 , a control system 200 , and a valve and fluid system 300 .

FIG. 3 illustrates an embodiment of the airbag cover system 100 . As shown in FIG. 3 , the helical pressure bladder jacket system 100 includes a helical pressure bladder jacket 105 and a helical pressure bladder 110 . In a specific embodiment, the helical pressure bladder 110 includes an upper width W1 112, a lower width W2 114, a length L 116 and a helix angle 118, wherein the length L 116 is a straight line connecting the midpoints of the widths W1 112 and W2 114. String. The helix angle is the angle between the length L 116 and the horizontal line parallel to the ground, when the user wears the airbag jacket in an upright posture. If W2 is parallel to the horizontal line as shown in FIG. 3, the helix angle is the angle between the width W2 and the length L116. In another embodiment, the helical pressure bladder casing 105 further includes one or more bladder casing fasteners 120 .

In the above-mentioned specific embodiment, the helical pressure balloon 110 is placed above the inner thigh aorta or main venous blood vessel, so that the helical shape of the helical pressure balloon 110 follows the aorta and main venous blood vessels around the thigh in the first figure. Bone path. The upper width W1 112, the lower width W2 114, the length L 116 and the helix angle 118 may vary with the placement position and the user's physiological signals (such as gender, height, weight, BMI, age, etc.) to better fit around the thigh Aortic vessels and main venous vessels of bone. In a specific embodiment, the helix angle 118 is between about 30° to 75°, 40° to 65°, or about 55°. In a specific embodiment, the upper width W1 112 of the helical pressure bladder is greater than the lower width W2 114 , as shown in FIG. 3 . In another specific embodiment, the ratio of W1 112 to W2 114 is between about 2:1 to 1:1, about 1.9:1 to 1.1:1, about 1.8 to 1.2:1, about 1.7:1 to 1.3:1 , between about 1.6:1 to 1.4:1, or about 1.5:1. Since W1 112 is wider than W2 114, when the helical pressure bladder 110 is inflated as shown in Figures 4a and 4c, blood flow can be pushed up the torso. In a specific embodiment, the ratio of the top width W1 112 of the helical pressure bladder 110 to the bladder length L 116 is about 1:2 to 1:4, or about 1:3.

In a specific embodiment, the helical pressure bladder 110 covers only the thigh area. In another specific embodiment, the helical pressure bladder 110 does not cover the entire thigh area, but only covers the surrounding thigh Sufficient areas above the aortic or main venous vessels of the bone to modulate blood flow in a therapeutically effective manner allow the balloon sheath system 100 and external counterpulsation device 10 to be miniaturized. In one embodiment, L 116, W1 112, and W2 114 are all dependent on the user's physiological signals, such as the user's height and/or weight. For example, in one embodiment, L=(user height/3.2)-b, where b is between about 15 cm and about 30 cm. If the user's height is 165 cm, L can be between about 21.6 cm and 36.6 cm, and W1 112 is about 14 cm, and W2 114 is about 14 cm.

In one embodiment, as shown in FIG. 3 , the airbag cover system 100 further includes an auxiliary airbag cover 160 . In one embodiment, the accessory air bag cover 160 includes an accessory air bag 170 that assists the helical pressure air bag 110 to push blood flow toward or out of the user's torso, which will be described in detail later in conjunction with FIGS. 4 to 6 . Considering the design of the helical pressure bladder 110, the width W 180 and the length L 185 of the auxiliary bladder 170 should be minimized to reduce the required power and size of the air compressor for inflation, but the helical pressure bladder must still be provided 110 appropriate assistance, which will be described later in conjunction with Figure 4. However, the width W 180 of the auxiliary air bag 170 should be wide enough that when the auxiliary air bag cover 160 is located at the lower end of the helical pressure air bag cover 105 (as shown in Figures 4a and 4c ), the auxiliary air bag 170 must completely cover the width of the spiral pressure air bag 110 The width W2 114, or the width W1 112 of the helical pressure bladder 110 must be completely covered by the accessory bladder 170 when the accessory bladder jacket 160 is located at the upper end of the helical pressure bladder jacket 105 (as shown in Figures 4b and 4d). In addition, the length L 185 and the width W 180 of the auxiliary air bag 170 should have a certain size, and the pressure provided by the air compressor should be high enough to provide an appropriate force to assist the helical pressure air bag 110 to adjust the blood flow to the desired direction, as described later. With the description of the configuration in Figure 4. In a specific embodiment, the ratio of the width W 180 to the length L 185 of the satellite bladder 170 is about 1.5:1 to 4:1, about 2:1 to 3:1, or about 2.5:1. In another specific embodiment, the width W 180 of the accessory airbag is about 8 cm to 30 cm, 16 cm to 24 cm, or about 22 cm.

In a specific embodiment, as shown in Figures 4a to 4d, the auxiliary bladder 170 may be placed over the helical pressure bladder 110 in various configurations. In one embodiment, the auxiliary bladder 170 may be positioned above the lower end of the helical pressure bladder 110, as shown in Figure 4a. In a specific embodiment, the accessory bladder 170 The bottom of the helical pressure bladder W2 114 is adjacent to the lower end of the helical pressure bladder and overlaps with the helical pressure bladder 110 . In yet another embodiment, the helical pressure bladder 110 and the auxiliary bladder 170 may be located in the same bladder casing, as shown in Figure 4c.

In another specific embodiment, as shown in FIG. 4b , the auxiliary air bag 170 may be placed on the upper end of the helical pressure air bag 110 . In a specific embodiment, the auxiliary air bag 170 adjoins the upper end of the spiral pressure air bag at the top of the spiral pressure air bag W1 112 and overlaps the spiral pressure air bag 110 . In yet another embodiment, the helical pressure bladder 110 and the auxiliary bladder 170 may be located in the same bladder casing, as shown in Figure 4d.

In a specific embodiment, the auxiliary air bag 170 is inflated before the helical pressure air bag 110 to control the blood flow after the helical pressure air bag 110 is inflated. Specifically, as shown in FIG. 5 , when the auxiliary air bag 170 is located at the lower end of the helical pressure air bag 110 and is inflated before the helical pressure air bag 110 , most of the blood flow driven by the air bag covering system 100 will flow upward to the user. the person's torso because the accessory bladder 170 prevents blood flow down. In a specific embodiment, the satellite bladder 170 should be wide enough to cover at least the full width of the adjacent helical pressure bladder width W1 112 . In addition, the air pressure of the accessory bladder 170 should be high enough to prevent about 90%, about 80%, about 70%, or about 60% of the blood flow downward when inflated. In a specific embodiment, the pressure in the helical pressure bladder 110 and the auxiliary bladder 170 is about 150 mmHg to 350 mmHg, about 200 mmHg to 300 mmHg, or about 250 mmHg. Then, when the accessory bladder 170 and the helical pressure bladder 110 are deflated, most of the blood flow driven by the bladder housing system 100 flows down the user's torso. In FIG. 6, in one embodiment, when the auxiliary air bag 170 is located in the upper half of the helical pressure air bag 110 and the auxiliary air bag 170 is inflated before the helical pressure air bag 110, the blood flow driven by the air bag covering system 100 is large. Part of it flows down to the user's foot because the accessory bladder 170 prevents the blood from flowing upwards. Then, when the accessory bladder 170 and the helical pressure bladder 110 are deflated at the same time, most of the blood flow driven by the bladder housing system 100 flows upward toward the user's torso. Therefore, the air pressure of the accessory bladder 170 should be high enough to prevent about 90%, about 80%, about 70%, or about 60% of the blood flow upwards after being inflated. in a specific In an embodiment, the pressure in the helical pressure bladder 110 and the auxiliary bladder 170 is about 150 mmHg to 350 mmHg, about 200 mmHg to 300 mmHg, or about 250 mmHg. As shown in FIG. 5 and FIG. 6 , with the placement of the helical pressure airbag 110 and the auxiliary airbag 170 in different positions, different body parts of the user can receive treatment of different intensity.

In a specific embodiment, as shown in FIG. 7 , the external counterpulsation device 10 of the present invention further includes an external counterpulsation control system 200 configured to control various aspects of the external counterpulsation device 10 of the present invention, including but not Limited to interacting with the user, collecting and analyzing the user's physiological signals, and interacting with the valve and fluid system 300 to inflate/deflate the helical pressure bladder 110 and accessory bladder 170 . In a specific embodiment, the external counterpulsation control system 200 preferably includes an external counterpulsation processing unit 210, one or more heartbeat sensors (including a PPG sensor 220, an ECG sensor 230, a continuous blood pressure sensor 240) and an interactive display unit 250. In a specific embodiment, the external counterpulsation processing unit 210 is connected to the interactive display unit 250 and the heartbeat sensor (including the PPG sensor 220 , the ECG sensor 230 and the continuous blood pressure sensor 240 ) through the circuit connection 260 connected. In addition, in a specific embodiment, the external counterpulsation processing unit 210 is further connected to a valve and fluid system 300 through the circuit connection 260 , which will be described in detail later with reference to FIGS. 8 and 10 .

In a specific embodiment, the external counterpulsation processing unit 210 preferably includes a processor configured to transmit, receive and process signals, including but not limited to signals transmitted to and from the user through the interactive display unit 250, Signals sent to and from valve and fluid system 300, signals related to the user's physiological signals, such as self-heart rate sensors (including PPG sensor 220, ECG sensor 230, and continuous blood pressure sensor 240) Heartbeat information collected. As such, the external counterpulsation processing unit 210 is configured to control various aspects of the external counterpulsation device 10 of the present invention, such as the air pressure in the helical pressure airbag 110 and the air pressure in the auxiliary airbag 170 , based on various processed signals.

As shown in FIG. 7, in one embodiment, the PPG sensor 220 may include a finger sensor 220a and two toe sensors 220b and 220c. In one embodiment, the ECG sensor 230 may include a right chest and left chest sensors 230a and 230b. Additionally, the ECG sensor 230 may further include legs part sensor 230c. In one embodiment, the continuous blood pressure sensor 240 includes a sphygmomanometer balloon jacket placed on the user's arm.

The interactive display unit 250 is preferably a touch screen, allowing the user to interact with the external counterpulsation device 10 of the present invention, such as starting the external counterpulsation therapy, inputting user information, system settings, and the like. The user information may include the user's physiological signals, such as gender, height, weight, BMI, age, and the like. The input information may also include system settings, such as the type and duration of external counterpulsation therapy, maximum and/or minimum pressure, etc. The output information can include treatment type, treatment progress, etc.

In a specific embodiment, as shown in FIG. 8 and FIG. 9, the external counterpulsation device of the present invention 10 further includes a valve and a fluid system 300, which can control the external counterpulsation control system 200 of the present invention 10 together. The internal pressure of the external counterpulsation device includes the internal pressure of the valve and the fluid system 300 and the airbag covering system 100 . In a specific embodiment, the valve and fluid system 300 includes one or more airbag valves 310 , a pressure-regulated air storage tank 320 , an air pressure proportional adjustment valve 330 , an air compressed air storage tank 340 , and an air compressor 350 . , air pressure to electrical signal transmitter 360, air supply valve 370, air inlet 375 and a series of large gas lines 380 and small gas lines 390 and 395. In a specific embodiment, the diameter of the large gas pipeline 380 for producing negative pressure is about 1 to 10 cm, and the diameter of the small gas pipelines 390 and 395 is about 0.4 cm to 2 cm.

In a specific embodiment, each air bag valve 310 preferably includes a valve configured to adjust the air bag cover system 100 based on electrical signals received from the external counterpulsation control system 200 . In a specific embodiment, the balloon valve 310 is a solenoid valve. The regulated air storage tank 320 preferably includes an air storage tank that can store pressurized air for inflating the helical pressure bladder 110 and the auxiliary bladder 170 . In a specific embodiment, the internal pressure of the regulated air storage tank 320 is between 150mmHg to 350mmHg, 200mmHg to 300mmHg, or about 250mmHg. Each of the valves 310a and 310b is connected to the pressure-regulated air storage tank 320 through a small gas line 390, and is connected to the helical pressure air bag 110 and the auxiliary air bag 170 at the other end of the valve through a small air line 395. Each air bag valve 310 is further connected to the air supply valve 370 and the compressor 350 through the atmospheric gas line 380 , and the helical pressure air bag 110 and the auxiliary air bag 170 can be exhausted through the atmospheric gas line 380 . In addition, each gas The bladder valve 310 is electrically connected to the external counterpulsation processing unit 210 through the circuit connection 260 , and the external counterpulsation processing unit 210 can electrically drive the bladder valve 310 to inflate or deflate the spiral pressure bladder 110 and the auxiliary bladder 170 .

In a specific embodiment, the compressed air storage tank 340 includes an air storage tank, which is connected to the pressure-regulated air storage tank 320 through the air pressure proportional adjustment valve 330 . In a specific embodiment, the air pressure proportional adjustment valve 330 is further connected to the external counterpulsation processing unit 210 through the circuit connection 260 . In this way, the air pressure proportional adjustment valve 330 is configured to maintain the air pressure in the pressure-regulated air storage tank 320 and the compressed air storage tank 340 based on the signal from the external counterpulsation processing unit 210 . In a specific embodiment, the air pressure in the air storage tank 320 after the pressure regulation is maintained between about 150mmHg to 350mmHg, 200mmHg to 300mmHg, or about 250mmHg. The air pressure in the compressed air storage tank 340 is maintained at about 4kgf to 8kgf, about 5kgf to 7kgf, or about 6kgf.

In one embodiment, the air compressor 350 includes an air compressor configured to provide positive pressure in the small gas line 390 when the supplemental valve 370 is open, and to provide large gas when the supplemental valve 370 is closed to the air inlet 375 Line 380 is under pressure to allow supplemental gas to flow into compressed air storage tank 340 and to exhaust helical pressure bladders 110 and 117, respectively. In a specific embodiment, the air compressor 350 can operate at about 1700 rpm and a flow rate of about 130 L/m, and the maximum pressure can be about 8 kgf. The supplemental air valve 370 preferably includes a valve connected at one end to the compressor 350 via the atmospheric gas line 380 and connected to the air inlet 375 at the other end. In one embodiment, the supplemental gas valve 370 includes a solenoid valve.

Finally, transmitter 360 preferably includes a plurality of transmitters, each transmitter converting pressure into an electrical signal. Each transmitter 360 is preferably connected to the compressed air storage tank 340 and the pressure-regulated air storage tank 320 at one side through a small gas line 390 , and is also connected to the external counterpulsation processing unit 210 . As such, valve and fluid system 300 is configured to transmit air pressure information to external counterpulsation control system 200 via transmitter 360 . As described above, the external counterpulsation processing unit 210 is connected to the air bag valve 310, the air pressure proportional adjustment valve 330, the supplemental air valve 370, and the air compressor 350, so that the external counterpulsation control system 200 is configured to send electrical signals to transmit-based The air pressure information sent by the devices 360a and 360b is used to control the air pressure proportional adjustment valve 330 and the air supply Valve 370 and air compressor 350.

In a specific embodiment, when the external counterpulsation processing unit 210 sends a signal to the air bag valve 310, the air bag valve 310 will pressurize the air bag 310 by connecting the helical pressure air bag 110 and the auxiliary air bag 170 to the pressure-regulated air storage tank 320. The gas is fed into the helical pressure airbag 110 and the auxiliary airbag 170 to inflate the helical pressure airbag 110 and the auxiliary airbag 170 . When the helical pressure air bag 110 and the auxiliary air bag 170 are deflated, the external counterpulsation processing unit 210 stops sending any signal to the air bag valve 310, so that the air bag valve 310 is preset to disconnect the spiral pressure air bag 110 and the auxiliary air bag 170 and adjust the air bag valve 310. After the connection of the air storage tank 320 is compressed, the helical pressure air bag 110 and the auxiliary air bag 170 are connected to the atmospheric gas line 380 . In addition, the external counterpulsation processing unit 210 also sends a signal to the air supply valve 370 to close the gas inlet, so that the air compressor 350 forms a negative pressure in the atmospheric gas pipeline 380 , and quickly discharges the spiral pressure air bag 110 and the auxiliary air bag 170 gas. In a specific embodiment, the negative pressure in atmospheric line 380 is between about 80 mmHg to 120 mmHg, about 90 mmHg to 110 mmHg, or about 100 mmHg.

FIG. 10 illustrates a method of providing the external counterpulsation therapy of the present invention 1000 . The method of the present invention can be used to treat stroke, dementia, atherosclerosis and other diseases, and can also be used only to improve blood flow. As shown in FIG. 11, at step 1100, the method of the present invention is triggered and started. In one embodiment, step 1100 may be manually inserted by a person (eg, a user) through the interactive display unit 250 . In another embodiment, step 1100 may be automatically initiated via signals from heartbeat sensors (including PPG sensor 220 , ECG sensor 230 , continuous blood pressure sensor 240 ). Next, in step 1105, the external counterpulsation processing unit 210 reads and analyzes various physiological signals, such as but not limited to input by the user through the display and through the PPG sensor 220, the ECG sensor 230, the continuous blood pressure sensing The device 240 and the like are input to determine the R Peak of the user's heartbeat. After the R Peak is determined in step 1105 by various conventional methods, the external counterpulsation processing unit 210 sets a value between about 10ms to 250ms, about 50ms to 200ms, or about 100ms to 150ms after the R Peak in step 1110 delay between. At step 1115, it is determined whether to supply air to the valve and fluid system 300 during the delay. In a specific embodiment, the external counterpulsation processing unit 210 is based on Step 1115 is executed for the air pressure signals from the transmitters 360a and 360b, and the transmitters 360a and 360b provide air pressure information to the pressure-regulated air storage tank 320 and the compressed air storage tank 340, respectively. In step 1115, if it is determined that it is not necessary to supply air to the air storage tank 320 and the compressed air storage tank 340 after the pressure adjustment, for example, when the pressure in the air storage tank 320 and the compressed air storage tank 340 after the pressure adjustment is maintained at Between about 150mmHg and 350mmHg, between about 200mmHg and 300mmHg, or about 250mmHg, no supplemental gas is required. In step 1120 , the external counterpulsation processing unit 210 drives the valve 310 b so that the valve 310 b connects the auxiliary air bag 170 with the pressure-regulated air storage tank 320 to inflate the auxiliary air bag 170 . In addition, in step 1220, the external counterpulsation processing unit 210 drives the valve 310a, so that the valve 310a connects the helical pressure bladder 110 with the pressure-regulated air storage tank 320, so as to use the air from the pressure-regulated air storage tank 320 to replace the screw The shaped pressure bladder 110 is inflated. In a specific embodiment, step 1120 is performed before step 1220, wherein a delay is inserted between steps 1120 and 1220, which is between about 30-70 ms, or between about 40-60 ms, or about 50 ms.

At step 1125, the inflation time of the accessory airbag 170 ends. In a specific embodiment, the inflation time is between about 200ms to 600ms, 250ms to 550ms, 300ms to 500ms, or about 400ms. In a specific embodiment, the inflation time may be determined based on the heart rate, as shown in the following table:

In a specific embodiment, the external counterpulsation processing unit 210 performs step 1125 by tracking the inflation time. Next at step 1130, the auxiliary air bag 170 is deflated. In a specific embodiment, the venting step is performed by the external counterpulsation processing unit 210, which sends a signal to the valve 310b, so that the valve 310b disconnects the air bag 170 from the pressure-regulated air storage tank 320 and connects it to the atmospheric gas line 380 , and close the air supply valve 370, so that the air compressor 350 forms a negative pressure in the atmospheric gas line 380, so that the auxiliary air bag 170 is quickly exhausted. Next, in step 1135, the exhaust time of the auxiliary air bag 170 ends. In a specific embodiment, the external counterpulsation processing unit 210 executes step 1135 by tracking the exhaust time. In step 1140, the exhaust of the auxiliary air bag 170 is completed. If the curative effect is not fully exerted, the process returns to step 1105 to repeat the whole process.

Likewise, after maintaining the air pressure in the helical pressure bladder 110 for a predetermined period of time, in step 1225, the inflation time of the helical pressure bladder jacket 105 ends. In a specific embodiment, the inflation time is between about 200ms to 600ms, 250ms to 550ms, 300ms to 500ms, or about 400ms. In another embodiment, the air pressure in the helical pressure bladder 110 is maintained according to the user's heart rate in Table 1 minus any delay between steps 1120 and 1220 as previously described. In a specific embodiment, the external counterpulsation processing unit 210 performs step 1225 by tracking the inflation time. At step 1230, the helical pressure bladder 110 is vented. In a specific embodiment, the venting step is performed by the external counterpulsation processing unit 210, which sends a signal to the valve 310a, so that the valve 310a disconnects the helical pressure bladder 110 from the pressure-regulated air storage tank 320, and changes it to a larger one. Gas line 380 is connected. At this time, close the air supply valve when the air compressor 350 continues to operate 370 to create negative pressure and deflate the airbag. Next, in step 1235, the exhaust time of the helical pressure bladder 110 ends. In a specific embodiment, the external counterpulsation processing unit 210 executes step 1235 by tracking the exhaust time. In step 1240, the auxiliary air bag 170 is exhausted, and the process returns to step 1105 to repeat the whole process.

In one embodiment, steps 1125 and 1225 are performed at the same time, and steps 1130 and 1230 are also performed at the same time, so that the helical pressure bladder 110 and the auxiliary bladder 170 are vented simultaneously. In another embodiment, step 1125 is performed before step 1225 , and step 1130 is performed before step 1230 , so that the auxiliary bladder 170 is vented before the helical pressure bladder 110 . In this particular embodiment, the delay is between about 20ms to 100ms, 30ms to 90ms, 40ms to 80ms, or about 60ms. In another embodiment, step 1125 is performed after step 1225 , and step 1130 is performed after step 1230 , so that the auxiliary air bag 170 is deflated after the helical pressure air bag 110 . In this particular embodiment, the delay is between about 20ms to 100ms, 30ms to 90ms, 40ms to 80ms, or about 60ms.

In step 1115, if the external counterpulsation processing unit 210 determines that it is necessary to supply air to the pressure-regulated air storage tank 320 and the compressed air storage tank 340, then steps 1120 to 1140 and steps 1220 to 1240 are performed as described above, but steps 1305 to 1305 1315 was also performed to send more air into the system. Specifically, in step 1305 , the external counterpulsation processing unit 210 sends a signal to the air supply valve 370 to open the air supply valve 370 to the air inlet 375 and ensure the operation of the air compressor 350 to replenish the compressed air storage tank 340 Air. The air pressure proportional adjustment valve 330 then adds air to the regulated air storage tank 320 . In step 1310 , when the air supplement time is about to end, in a specific embodiment, the external counterpulsation processing unit 210 tracks the air supplement process in step 1310 . In step 1315, the external counterpulsation processing unit 210 sends a signal to close the air supply valve 370 to stop the flow of air into the valve and the fluid system. In a specific embodiment, since the airbag deflation process needs to close the air supply valve 370 so that negative pressure is formed in the atmospheric gas line 380 , before steps 1120 and 1220 are performed or after steps 1140 and 1240 are completed, steps 1305 to 1315 It is performed concurrently with steps 1120 to 1125 and 1220 to 1225 .

FIG. 11 illustrates the method of the present invention 1000 . As shown in FIG. 11, it is detected in step 1105 To R Peak, and before inflating the accessory bladder 170 at step 1120 , a delay of between about 10 ms to about 250 ms, about 50 ms to about 200 ms, or about 100 ms to about 150 ms is placed at step 1110 . The helical pressure bladder 110 is then inflated at step 1220 after a delay of about 50 ms when the auxiliary bladder 170 is inflated. FIG. 11 also shows that if it is determined in step 1115 that air needs to be supplemented, air is supplemented in steps 1305 to 1315 when the auxiliary air bag 170 starts to inflate for about 50 ms to about 100 ms. Next, in steps 1125 to 1140 and steps 1225 to 1240, the auxiliary air bag 170 and the helical pressure air bag 110 are exhausted at about the same time.

FIG. 12 illustrates the curative effect of the external counterpulsation device 10 of the present invention. As shown in Figure 12, the PPG signal of the user before the treatment was very weak. During the treatment, the user's PPG signal is more stable and maintained at a stable intensity, as shown in Figure 12b.

It is to be understood that the foregoing general and detailed descriptions have been presented by way of example and explanation only and are not intended to limit the invention.

The foregoing and other changes may be made to the present invention with reference to the foregoing detailed description. In general, terms used in this disclosure should not be construed as limiting the invention to the scope of specific embodiments unless the foregoing description provides an explicit definition. Accordingly, the true scope of the invention encompasses the specific embodiments disclosed, as well as all equivalents for implementing or implementing the invention.

110: Spiral pressure bladder

170: Auxiliary airbag

Claims (14)

An external counterpulsation device, comprising: a. an airbag system, comprising one or more helical pressure airbags and one or more auxiliary airbags, wherein when each helical pressure airbag is adhered to the user's thigh, it will follow the femur. The aortic blood vessels and the main venous blood vessels form a spiral shape. When the helical pressure balloon is inflated, it exerts effective pressure on the aortic blood vessels and/or the main venous blood vessels and sticks to the femur, so as to regulate the aortic blood vessels and the main venous blood vessels. blood flow in a blood vessel; b. a valve and fluid system connected to the balloon system, wherein the valve and fluid system are configured to inflate or deflate the helical pressure balloon and ancillary balloons; and c. a control system, Including a processing unit and one or more photoplethysmography (PPG) sensors and one or more electrocardiogram (ECG) sensors, wherein the PPG and ECG sensors are connected to the user to collect data from the user and wherein the control system is electrically connected to the valve and fluid system to control the valve and fluid system, and to inflate or deflate the air bags in the air bag system based on the signals measured by the sensors, And wherein the auxiliary air bag is located at the upper end or the lower end of the helical pressure air bag, and is inflated before the helical pressure air bag, so as to guide the blood flow to the desired direction. The external counterpulsation device of claim 1, wherein the size of the helical pressure bladder is determined by the anatomy of the user, so that the helical pressure bladder can follow the aortic vessels of the user's thigh and main vein. The external counterpulsation device according to claim 1, wherein the length L of the helical pressure bladder is in centimeters, and is defined as "user's height/3.2-b", wherein b is between 15 cm and 30 cm Between centimeters, the top width (W1) and the bottom width (W2) of the helical pressure airbag are each about 14 centimeters, and the helix angle is about 55°. The external counterpulsation device as described in claim 1, wherein the valve and fluid system The power of the system is less than about 1500 watts. The external counterpulsation device according to claim 3, wherein the length L of the helical pressure bladder does not exceed about 50 cm, W1 and W2 do not exceed about 25 cm, and the area does not exceed about 1250 cm2. The external counterpulsation device of claim 1, wherein the pressure in the helical pressure bladder does not exceed about 350 mmHg when fully inflated. The external counterpulsation device of claim 1, wherein the pressure in the helical pressure bladder is not less than about 150 mmHg when fully inflated. The external counterpulsation device according to claim 1, wherein the ratio of the top width W1 to the bottom width W2 of the helical pressure balloon is about 1:1 to 2:1. The external counterpulsation device of claim 1, wherein the helical angle of the helical pressure balloon is between about 30° to 75°. The external counterpulsation device according to claim 1, wherein the auxiliary air bag is located at the lower end of the helical pressure air bag and covers the helical pressure air bag. The external counterpulsation device according to claim 1, wherein the auxiliary air bag is located at the lower end of the helical pressure air bag, but does not cover the spiral pressure air bag. The external counterpulsation device according to claim 1, wherein the auxiliary air bag is located at the upper end of the helical pressure air bag and covers the helical pressure air bag. The external counterpulsation device according to claim 1, wherein the auxiliary air bag is located at the upper end of the helical pressure air bag, but does not cover the helical pressure air bag. The external counterpulsation device as claimed in claim 1, wherein the auxiliary air bag and the helical pressure air bag are both located in the same air bag casing.

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